Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.

Key Inclusion Criteria:

- Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.

- Persistent disabling Parkinson's disease symptoms or drug side effects (e.g.,
dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical
therapy.

- Able to understand the study requirements and the treatment procedures and provides
written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

- Any intracranial abnormality or medical condition that would contraindicate DBS
surgery.

- Have any significant psychiatric condition likely to compromise the subject's ability
to comply with requirements of the study protocol

- Any other active implanted devices including neurostimulators and /or drug delivery
pumps

- Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.

- Have any significant medical condition that is likely to interfere with study
procedures or likely to confound evaluation of study endpoints.

- A female who is breastfeeding or of child-bearing potential with a positive urine
pregnancy test or not using adequate contraception.